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Development Pipeline Progress Status (Summary) in Third Quarter of Fiscal Year Ending March 31, 2017

Development Pipeline Progress Status (Summary) in Third Quarter of Fiscal Year Ending March 31, 2017 The followings summarize the changes in development status progressed from the announcement of financial results at the 2 nd Quarter of the fiscal year released on November 7, 2016. For details, please refer to pages 12 to 17 of the 3 rd Quarter Flash Report (Filing, 3 mnth, MAR 31, Ono, 2017, MAR 31, 2017, View Source [SID1234519525]). Development status of ONO products excluding ONO-4538/Opdivo (nivolumab) (Japan) Parsabiv  Intravenous Injection for Dialysis (ONO-5163/etelcalcetide hydrochloride), a calcium sensing receptor agonist An application for manufacturing and marketing approval of Parsabiv was approved for the treatment of secondary hyperparathyroidism on hemodialysis on December 19, 2016. The NHI price listing is expected to be this February. Orencia  Subcutaneous Injection (ONO-4164/ BMS-188667), a T-cell activation inhibitor Global Phase III clinical study of Orencia was started for the treatment of primary Sjögren syndrome. ONO-4578, a Prostaglandin E2 receptor (EP4) antagonist Phase I clinical study of ONO-4578 was initiated for solid tumor. (Outside of Japan) ONO-4059, a Bruton’s tyrosine kinase (Btk) inhibitor Phase II clinical study of ONO-4059 was started for the treatment of B cell lymphoma in the US by our licensee, Gilead Sciences, Inc. ONO-7475, an Axl /Mer inhibitor Phase I clinical study of ONO-7475 was initiated for the treatment of acute leukemia in the US. ONO-7579, a Tropomyosin receptor kinase (Trk) inhibitor Phase I clinical study of ONO-7579 was initiated for solid tumor in Europe and the US. ONO-2952, a Translocator protein (TSPO) antagonist ONO-2952 had been developed for potential treatment of diseases caused due to stress by suppressing the production of neuroprotein causing stress. However, the development of ONO-2952 for the treatment of irritable bowel syndrome was discontinued due to the strategic reason considering differentiation among existing products and competing products under development and others comprehensively. ONO-4232, a P rostaglandin E2 receptor (EP4) agonist The development of ONO-4232 for the treatment of acute heart failure was discontinued due to the strategic reason considering future development period, development cost and others comprehensively. Development status of ONO-4538/Opdivo (nivolumab), etc. ONO-4538/Opdivo (Japan, South Korea and Taiwan)-An application of Opdivo for a partial change in approved items of the manufacturing and marketing authorization was approved for additional indication of relapsed or refractory classical Hodgkin lymphoma, a blood cancer, in Japan on December 2, 2016.-An application of O pdivo for a partial change in approved items of the manufacturing and marketing authorization was submitted for the indication of unresectable advanced or recurrent gastric cancer in Japan on December 27, 201 6.-Phase III clinical study was started for the treatment of ovarian cancer in Japan. ONO-4538/ Opdivo (US and Europe)-In the US, a supplemental Biologics License Application (sBLA) of Opdivo was approved for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.-In Europe, Opdivo was approved for additional indication of relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.-In the US, Phase I clinical study was initiated for the treatment of sepsis. ONO-4686/BMS-986207, an Anti-TIGIT antibody (Japan, South Korea and Taiwan) Phase I/II clinical study was initiated for solid tumors in Japan.

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Propanc Authorizes Reverse Stock Split and Corporate Name Change to Propanc Biopharma, Inc.

On March 31, 2017 Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that its Board of Directors has approved a corporate name change and ratio for the reverse stock split of the issued and outstanding shares of common stock (Press release, Propanc, MAR 31, 2017, View Source [SID1234518414]). The Company had previously announced that the Board and a majority of its voting stockholders had approved a range for a reverse stock split and a reduction in the number of authorized shares of common and preferred stock of the Company.

The Company’s name will change to Propanc Biopharma Inc. on April 7, which symbolizes a new and exciting growth phase for the Company, as it heads towards First-In-Man studies for its lead product, PRP.

Also, it is expected that prior to the commencement of trading on April 7 a 1-for-250 reverse stock split will be effectuated. The number of authorized shares of common stock will be reduced from 2 billion to 100 million and the number of authorized shares of preferred stock of the Company reduced from 10 million to just over 1.5 million. Investors should note that for 20 trading days after the reverse stock split, the ticker symbol of the Company’s common stock will change to PPCHD.

"As a result of the Company’s recent progress and anticipated upcoming milestones, we believe the timing is right to change our Company name to better reflect our stage of growth and development, as well as execute the reverse stock split," said James Nathanielsz, Propanc’s Chief Executive Officer. "Given that we expect to complete our GLP toxicity study very soon and expect to then move forward with First-In-Man studies of our lead product, PRP, we wanted to launch our corporate strategy to address our capital structure, reduce debt, and raise additional capital sufficient to progress PRP through clinical development. By undertaking these steps, management hopes to better position the Company for an up-listing of our common stock to a national stock exchange in order to help ensure the long-term future of the Company and create value for its shareholders."

The Company’s lead product, PRP, is a novel, patented, formulation consisting of two pancreatic proenzymes, trypsinogen and chymotrypsinogen. Currently in preclinical development and progressing towards First-In-Man studies, PRP aims to prevent tumor recurrence and metastasis in solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. The Company’s initial target patient populations include pancreatic, ovarian and colorectal cancers.

To view Propanc’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc’s email distribution list, please email [email protected] with "Propanc" in the subject line.

Phase II Copanlisib Data Show Durable Tumor Response in Indolent Non-Hodgkin’s Lymphoma

On March 31, 2017 Bayer reported positive data on its investigational compound copanlisib, an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms (Press release, Bayer, MAR 31, 2017, View Source;dcp=Phase-II-Copanlisib-Data-Show-Durable-Tumor-Response-in-Indolent-Non-Hodgkins-Lymphoma&ccm= [SID1234518413]). The Phase II CHRONOS-1 trial, an open-label, single-arm study of copanlisib evaluating patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (iNHL), met its primary endpoint of a pre-specified objective response rate (ORR). The results across all patient groups show an ORR of 59.2%, with a 12% complete response (CR) rate and a median duration of response (DOR) of more than 98 weeks (687 days). These data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting in Washington, D.C., USA in the Novel Agent and Intervention Clinical Trials session on April 4, 2017 from 3:05 PM – 3:20 PM (ET).

"Based on the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines, inhibition of the PI3K pathway has been shown to be an effective therapeutic strategy in treating indolent lymphomas, like follicular lymphoma; however, concerns exist about the safety of available oral PI3K inhibitors, highlighting the need for new approaches," said Martin Dreyling, Professor of Medicine at the University of Munich Hospital in Grosshadern. "The results of CHRONOS-1 demonstrate that intermittent intravenous administration of copanlisib achieved durable efficacy with a manageable safety profile in this difficult-to-treat patient population."

The full analysis set comprised 142 patients, of which 141 patients had iNHL. At the time of analysis, median duration of treatment was 22 weeks and 46 patients remained on treatment. In the follicular lymphoma (FL) subset of CHRONOS-1 (n=104), copanlisib treatment resulted in an ORR of 58.7%, including a CR of 14.4% and a median DOR of more than 52 weeks (370 days). The safety and tolerability were consistent with previously published data on copanlisib. The most common treatment-related adverse events were transient hyperglycemia (all grades: 49%/Grade ≥3: 40%), which did not show severity above Grade 4 and hypertension (all grades: 29%/Grade ≥3: 23%), which did not show severity above Grade 3.

"NHL is the tenth most common cancer worldwide and one of the most common cancers in the U.S. Despite treatment advances, most indolent NHL patients relapse after, or are refractory to, current therapies," said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer. "The positive results from CHRONOS-1 are an important milestone and reflect the potential clinical utility of copanlisib in addressing the unmet medical need in patients with malignant lymphoma."

Other copanlisib data to be presented at AACR (Free AACR Whitepaper) 2017 include preclinical analysis of copanlisib activity in B-cell lymphomas as a single agent or in combination with conventional and targeted agents and a study on the binding affinity of copanlisib.

Bayer is in discussion with the U.S. Food and Drug Administration (FDA) with respect to a New Drug Application (NDA), seeking accelerated approval of copanlisib for the treatment of relapsed or refractory FL who have received at least two prior therapies. The company has been granted Fast Track Designation by the FDA for copanlisib for this indication. Fast Track is a program designed to facilitate the development, and expedite the review of drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Copanlisib was also granted Orphan Drug Designation (ODD) by the FDA Office of Orphan Products Development in the U.S. in February 2015 for the treatment of FL and in February 2017 for the treatment of splenic, nodal, and extranodal subtypes of marginal zone lymphoma (MZL). The ODD program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders. The FDA regards any disease that affects less than 200,000 patients in the U.S. as rare.

About CHRONOS-1
CHRONOS-1 is an open-label, single-arm Phase II study (ClinicalTrials.gov Identifier: NCT01660451) evaluating copanlisib as a monotherapy in non-Hodgkin’s lymphoma patients. CHRONOS-1 was designed to evaluate the efficacy and safety of copanlisib in patients with relapsed or refractory indolent NHL, including follicular lymphoma (FL), who received at least two prior therapies. The primary endpoint of CHRONOS-1 is the objective tumor response rate, with duration of response, overall survival, progression-free survival, quality of life, and safety serving as secondary endpoints.

About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma (NHL) is the most common hematologic malignancy and the tenth most common cancer worldwide, with nearly 386,000 new cases diagnosed in 2012. It accounts for nearly 200,000 deaths per year worldwide. NHL comprises a highly heterogeneous group of diseases that can be indolent or aggressive with a poor prognosis. Follicular lymphoma is the most common histological subtype of indolent NHL, for which there is a need to improve treatment options.

About Copanlisib
Copanlisib is a novel pan-class I PI3K inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms, being developed by Bayer. The PI3K pathway is involved in cell growth, survival and metabolism, and its dysregulation plays an important role in non-Hodgkin’s lymphoma (NHL). Copanlisib is administered as a 1-hour infusion on an intermittent weekly basis (3 weeks on/1 week off).

Copanlisib has shown promising clinical activity in Phase I and Phase II studies in heavily pretreated patients with recurrent indolent and aggressive NHL. The broad clinical development program also includes Phase III studies in indolent NHL patients who have relapsed or are refractory to prior therapies. Information about these trials can be found at www.clinicaltrials.gov and www.chronostrials.com.

Copanlisib is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

ASTRAZENECA COMPLETES AGREEMENT WITH TERSERA THERAPEUTICS FOR COMMERCIAL RIGHTS TO ZOLADEX IN THE US AND CANADA

On March 31, 2017 AstraZeneca reported that it has completed the agreement with TerSera Therapeutics LLC for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada (Press release, AstraZeneca, MAR 31, 2017, View Source [SID1234518408]). Zoladex is an injectable luteinising hormone-releasing medicine, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. It was first approved in the US and Canada in 1989.

Under the terms of the agreement, AstraZeneca has received a payment of $250 million from TerSera for the commercial rights to the medicine in the US and Canada. As AstraZeneca will maintain a significant ongoing interest in Zoladex in the US and Canada, the payment will be reported as Externalisation Revenue in the Company’s financial statements, and will be booked in the first quarter of 2017.

AstraZeneca will receive future sales-related income through milestones totalling up to $70 million, as well as recurring quarterly sales-based payments at mid-teen percent of sales. AstraZeneca will also manufacture and supply Zoladex to TerSera, providing a further source of ongoing income from Zoladex in the US and Canada.

Spectrum Pharmaceuticals Highlights Three Abstracts on ROLONTIS™ (eflapegrastim) and BELEODAQ® (belinostat) for injection at the American Association for Cancer Research (AACR) Annual Meeting in Washington, D.C., April 1-5, 2017

On March 31, 2017 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported key presentations of clinical and scientific data related to its products at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in Washington, D.C., from April 1-5, 2017 (Press release, Spectrum Pharmaceuticals, MAR 31, 2017, View Source [SID1234518393]).

The following ROLONTIS (eflapegrastim) related abstract is being presented at the AACR (Free AACR Whitepaper) meeting:

Monday, April 3, 2017:

Abstract # Type Title First Author Time
1347 Poster In vivo efficacy of eflapegrastim in rats with chemotherapy-induced neutropenia Kim 8:00 AM -12:00 PM

The following key BELEODAQ (belinostat) for injection related abstracts are being presented at the AACR (Free AACR Whitepaper) meeting:

Monday, April 3, 2017:

Abstract # Type Title First Author Time
1059 Poster Enhanced anti-tumor efficacy of a checkpoint inhibitor in combination with the HDAC inhibitor belinostat in a murine hepato-cellular carcinoma preclinical model Llopiz 8:00 AM-12:00 PM

2018 Poster Synergistic interactions between PLK1 and HDAC inhibitors in non-Hodgkin’s lymphoma cells occur in vitro and in vivo and proceed through multiple mechanisms Nguyen 1:00 PM-5:00 PM

For more information about the AACR (Free AACR Whitepaper) meeting and for a complete list of abstracts, please refer to the conference website at View Source!/4292.